Background
Intravenous administration of parenteral nutrition (PN) admixtures containing 4‐oil lipid injectable emulsion (ILE) in preterm neonates is usually prohibited because of limited clinical data. The authors evaluated the stability, safety, and efficacy of PN admixtures containing 4‐oil ILE, for the first time, in preterm neonates.
Methods
A series of PN admixtures were prepared for consecutive administration in preterm neonates over a period of 15 days. Admixture stability was assessed after 24 hours of storage at 25 and 37 °C via visual inspection and measurement of mean droplet size (MDS). Safety and efficacy of the admixtures in preterm neonates were assessed via serum triglyceride levels and body weight increase measurements, respectively.
Results
PN admixtures were stable at 25 °C and had MDS ˂500 nm. After 15 days, there was a significant increase in body weight (P ≤ .0001) and level of serum triglycerides (P ≤ .0001), compared with the level before PN administration.
Conclusions
PN admixtures containing 4‐oil ILE were stable at 25 °C and showed instability at 37 °C. Therefore, it is recommended to keep the temperature during administration of PN admixtures at 25 °C. PN admixtures were well tolerated and safe over a period of 8 days while providing a balanced fatty acid supply. Tight monitoring of serum triglyceride level is essential, particularly in neonates of low birth weight and/or young gestational age, to avoid hypertriglyceridemia. Hence, the use of these PN admixtures is expected to be beneficial in terms of being cost‐effective and reducing the contamination risks.
The aim of this study was to evaluate compatibility and stability of the maximum concentration used for binary admixture containing dobutamine and dopamine in 5% glucose. The maximum concentration of each drug was 5.76 mg/ml of dobutamine and 2.88 mg/ml of dopamine in 50 ml of 5% glucose. The physical compatibility of binary admixtures was assessed using visual inspection and pH determination immediately after preparation (at 0 time) and after 24 hrs. The chemical stability was assessed using high performance thin layer chromatoghraphy (HPTLC). The method is based on HPTLC separation of the two drugs followed by densitometric measurements of their spots at 254 nm using Camag TLC Scanner 3. The mobile phase comprised ethyl acetate : n-propanol : water : glecial acetic acid (60:24:9:3, v/v/v/v). The results revealed that no precipitation, gas evaluation, color change, pH change or chemical incompatibility were observed over the entire time of mixing of two drugs in 5% glucose solution.
The aim of this study was to evaluate compatibility and stability of the maximum concentration used for ternary admixture containing midazolam, dobutamine and dopamine in 5% glucose and 0.9% sodium chloride solutions. The maximum concentration of each drug was 0.144 mg/ml of midazolam, 5.76 mg/ml of dobutamine and 2.88 mg/ml of dopamine in 50 ml of 5% glucose or 0.9% sodium chloride solutions. The physical compatibility of ternary admixtures was assessed using visual inspection and pH determination of ternary admixtures immediately after preparation (at 0 time) and after 24 hrs. The chemical stability was assessed using high performance thin layer chromatoghraphy (HPTLC). The method is based on HPTLC separation of the three drugs followed by densitometric measurements of their spots at 254 nm using Camag TLC Scanner 3. The mobile phase comprised ethyl acetate : n-propanol : water : glecial acetic acid (60:24:9:3, v/v/v/v). There were no visual changes (such as precipitation, gas evaluation or change in color) during 24 hrs after preparation of admixture. Also, there was no change in pH values of admixtures during that time. The results revealed chemical stability of midazolam, dobutamine and dopamine over the duration of mixing (24 hrs) in 5% glucose or 0.9% sodium chloride solutions.
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